Peripheral Vascular Diseases Clinical Trial
Official title:
Allogeneic,Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like, Endometrial Cells; Administered Intramuscular
This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based interventions. Three doses of ERC will be examined. The hypothesis is that ERC administration will be well-tolerated and possibly induce a therapeutic benefit.
The purpose of the trial is to determine safety of intramuscularly derived menstrual
mesenchymal stem cells (otherwise known as Endometrial Regenerative Cells, or ERC) in
patients with critical limb ischemia ineligible for revascularization. Safety will be
defined as freedom from treatment associated adverse events. Efficacy parameters will
comprise endpoints of changes in ankle-brachial index, toe-brachial index, TcPO2, ulcer
healing, rest pain, quality of life, and reduction in amputation.
Patients will receive 25, 50, or 100 million menstrual derived mesenchymal stem cells
(Endometrial Regenerative Cells: ERC) in ten injections of 2.5, 5, or 10 million mesenchymal
stem cells suspended in a volume of 1 ml per injection. Injections will be spaced at least 2
centimeters apart from each other in the gastrocnemius muscle above the failed vascular
perfusion area.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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